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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device folders and injectors, intraocular lens (iol)
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AST PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICEL AG
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 271 271
2020 362 362
2021 289 289
2022 490 490
2023 330 330
2024 183 183

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 433 433
Device Contamination with Chemical or Other Material 388 388
Adverse Event Without Identified Device or Use Problem 234 234
Crack 205 205
Material Split, Cut or Torn 146 146
Scratched Material 142 142
Break 95 95
Contamination /Decontamination Problem 73 73
Defective Device 62 62
Failure to Eject 54 54
Physical Resistance/Sticking 36 36
Contamination 31 31
Material Twisted/Bent 25 25
No Apparent Adverse Event 23 23
Material Fragmentation 22 22
Use of Device Problem 19 19
Defective Component 19 19
Insufficient Information 18 18
Appropriate Term/Code Not Available 17 17
Failure to Advance 16 16
Particulates 15 15
Fracture 13 13
Mechanical Problem 10 10
Material Separation 10 10
Difficult to Advance 10 10
Activation, Positioning or Separation Problem 9 9
Difficult to Remove 8 8
Burst Container or Vessel 8 8
Device Handling Problem 7 7
Ejection Problem 6 6
Unintended Ejection 6 6
Inaccurate Delivery 6 6
Material Rupture 5 5
Mechanical Jam 5 5
Entrapment of Device 4 4
Difficult to Insert 3 3
Off-Label Use 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Deformation Due to Compressive Stress 3 3
Fitting Problem 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Product Quality Problem 2 2
Failure to Deliver 2 2
Failure to Fold 2 2
Material Protrusion/Extrusion 2 2
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Positioning 1 1
Complete Blockage 1 1
Premature Discharge of Battery 1 1
Biofilm coating in Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Material Puncture/Hole 1 1
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Stretched 1 1
Unstable 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Activation Problem 1 1
No Pressure 1 1
Operating System Becomes Nonfunctional 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination of Device Ingredient or Reagent 1 1
Expiration Date Error 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 741 741
Insufficient Information 552 552
No Known Impact Or Consequence To Patient 286 286
No Consequences Or Impact To Patient 106 106
Capsular Bag Tear 62 62
No Code Available 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Eye Injury 33 33
Foreign Body In Patient 30 30
Vitrectomy 26 26
Visual Impairment 18 18
Corneal Edema 11 11
Visual Disturbances 10 10
Vitreous Loss 7 7
Failure of Implant 7 7
Endophthalmitis 6 6
Foreign Body Sensation in Eye 6 6
Blurred Vision 6 6
No Information 5 5
Inflammation 5 5
No Patient Involvement 5 5
Corneal Abrasion 4 4
Device Embedded In Tissue or Plaque 4 4
Eye Pain 4 4
Unspecified Eye / Vision Problem 3 3
Edema 3 3
Hemorrhage/Bleeding 3 3
Halo 2 2
Intraocular Pressure Increased 2 2
Iritis 2 2
Uveitis 2 2
Vitreous Floaters 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Unspecified Tissue Injury 1 1
Pain 1 1
Increased Sensitivity 1 1
Discomfort 1 1
Injury 1 1
High Blood Pressure/ Hypertension 1 1
Hyphema 1 1
Macular Edema 1 1
Corneal Decompensation 1 1
Corneal Perforation 1 1
Corneal Scar 1 1
Corneal Touch 1 1
Failure to Anastomose 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Bacterial Infection 1 1
Conjunctivitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Rayner Intraocular Lenses Limited II Apr-21-2020
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